Colcardiol

PACKAGE LEAFLET: INFORMATION FOR THE USER

COLCARDIOL 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Rosuvastatin
Equivalent
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What COLCARDIOL is and what it is used for
2. What you need to know before taking COLCARDIOL
3. How to take COLCARDIOL
4. Possible side effects
5. How to store COLCARDIOL
6. Contents of the pack and other information

1. What COLCARDIOL is and what it is used for

COLCARDIOL belongs to a group of medicines called "statins".
It has been prescribed for you because:

• Your cholesterol level is high. This means you are at risk of heart attack or stroke. COLCARDIOL is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol levels.
• You have been prescribed a statin because changing your diet and increasing physical activity have not been sufficient to correct your cholesterol levels. While taking COLCARDIOL, you must continue your cholesterol-lowering diet and maintain regular physical exercise.

Or

• You have other risk factors that increase the likelihood of developing heart attack, stroke, or related health problems. Heart attack, stroke, and related health problems may be caused by a condition called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits inside the arteries.

Why it is important to continue taking COLCARDIOL
COLCARDIOL is used to correct levels of fatty substances in the blood known as lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and so-called "good" cholesterol (HDL-C).

• COLCARDIOL can reduce "bad" cholesterol and increase "good" cholesterol.
• It works by helping to block the body's production of "bad" cholesterol and also improves the body's ability to remove "bad" cholesterol from the blood.

For many people, high cholesterol does not affect how they feel, as it causes no symptoms.
However, if high cholesterol is not treated, fatty deposits can build up in the walls of blood vessels, leading to narrowing.
Sometimes, these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and thereby causing a heart attack or stroke.
By lowering cholesterol levels, the risk of having a heart attack, stroke, or related health problems is reduced.
You should continue taking COLCARDIOL even if your cholesterol levels have returned to normal, to prevent them from rising again and causing fatty deposits to form.
However, you must stop taking COLCARDIOL on medical advice or if you become pregnant.

2. What you need to know before taking COLCARDIOL

Do not take COLCARDIOL

• if you have previously had an allergic reaction to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding. If you become pregnant while taking COLCARDIOL, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking COLCARDIOL by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle cramps or muscle pain;
• if you are taking a combination of medicines consisting of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Additionally, do not take COLCARDIOL 40 mg (the highest dose):

• if you have moderate kidney problems (in case of any doubt, ask your doctor);
• if your thyroid gland is not functioning properly;
• if you have repeated or unexplained muscle cramps or pain, a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines;
• if you regularly consume large amounts of alcohol;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• if you are taking other cholesterol-lowering medicines called fibrates.

If you fall into any of the above categories (or have any doubts), you must consult your doctor and inform them.
Warnings and precautions
Talk to your doctor or pharmacist before taking COLCARDIOL if:

• you have kidney problems;
• you have liver problems;
• you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4);
• you have had repeated or unexplained muscle cramps or pain, a personal or family history of muscle problems, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle cramps or pain, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking COLCARDIOL or other related medicines;
• you regularly consume large amounts of alcohol;
• your thyroid gland is not functioning properly;
• you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; read section “Other medicines and COLCARDIOL”;
• you are currently taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and COLCARDIOL may lead to serious muscle problems (rhabdomyolysis); read section “Other medicines and COLCARDIOL”;
• if you are over 70 years of age (your doctor needs to choose the appropriate starting dose of COLCARDIOL for you);
• if you have severe respiratory failure;
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting dose of COLCARDIOL for you.

If you fall into any of the above categories (or are unsure):

• do not take COLCARDIOL 40 mg (the highest dose) and consult your doctor or pharmacist before starting COLCARDIOL at any dosage.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with COLCARDIOL. Discontinue use of COLCARDIOL and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test showing elevated liver enzyme levels. For this reason, your doctor will request this test (liver function test) before and during treatment with COLCARDIOL.

During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Children and adolescents

• if the patient is under 6 years of age: COLCARDIOL must not be administered to children under 6 years of age.
• if the patient is under 18 years of age: COLCARDIOL 40 mg tablets are not suitable for use in children and adolescents under 18 years of age.

Other medicines and COLCARDIOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation);
• warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood);
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• antacids (used to neutralize stomach acid);
• erythromycin (an antibiotic); fusidic acid (an antibiotic – see section “Warnings and precautions”);
• an oral contraceptive (the pill);
• regorafenib (used to treat tumors);
• darolutamide (used to treat tumors);
• capmatinib (used to treat tumors);
• fostamatinib (used to treat low platelet count);
• febuxostat (used to treat and prevent high levels of uric acid in the blood);
• teriflunomide (used to treat multiple sclerosis);
• hormone replacement therapy;
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• roxadustat (used to treat anemia in patients with chronic kidney disease);
• tafamidis (used to treat a disease called transthyretin amyloidosis).

The effects of these medicines may be altered by COLCARDIOL, or the effect of COLCARDIOL may be altered by these medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart COLCARDIOL. Taking COLCARDIOL with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take COLCARDIOL if you are pregnant or breastfeeding. If you become pregnant while taking COLCARDIOL, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with COLCARDIOL by using appropriate contraceptive measures.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Most people can drive and operate machinery while taking COLCARDIOL – it does not affect their ability to drive or operate machinery. However, some people may experience dizziness during treatment with COLCARDIOL. If you experience dizziness, consult your doctor before driving or operating machinery.

COLCARDIOL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), contact them before taking this medicine.

COLCARDIOL 40 mg contains the colouring agents sunset yellow (E110) and carmine red (E124)
These may cause allergic reactions.

3. How to take COLCARDIOL

Take this medicine exactly as prescribed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
Use in adults
If you are taking COLCARDIOL for high cholesterol:
Starting dose
Treatment with COLCARDIOL should begin with a dose of 5 mg or 10 mg, even if you have previously taken higher doses with other statins. The choice of starting dose depends on:

• your cholesterol level;
• your risk level for having a heart attack or stroke;
• whether you have any factors that may make you more sensitive to possible side effects.
  Check with your doctor or pharmacist which starting dose of COLCARDIOL is most suitable for you. Your doctor may decide to prescribe the lowest dose (5 mg) if you:
• are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• are over 70 years old;
• have moderate kidney problems;
• are at risk of muscle pain or cramps (myopathy).

Dose increase and maximum daily dose
Your doctor may decide to increase your dose in order to determine the most appropriate dose for you. If starting at 5 mg, your doctor may, if necessary, decide to double the dose to 10 mg, then to 20 mg, and then to 40 mg. If starting at 10 mg, your doctor may, if necessary, decide to double this dose to 20 mg and then to 40 mg. There must be an interval of 4 weeks between each dose adjustment.
The maximum daily dose of COLCARDIOL is 40 mg. This dose is administered only to patients with high cholesterol levels and at high risk of heart attack or stroke, whose cholesterol levels have not sufficiently decreased with the 20 mg dose.
If you are taking COLCARDIOL to reduce the risk of heart attack, stroke, or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the above-mentioned risk factors.

Use in children aged 6 to 17 years
The dosage range in children and adolescents aged 6 to 17 years is from 5 mg to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the most appropriate COLCARDIOL dose for the patient. The maximum daily dose of COLCARDIOL is 10 mg or 20 mg for children aged 6 to 17 years, depending on age, weight, and the underlying condition being treated. The dose should be taken once daily. COLCARDIOL 40 mg tablets must not be used in children.

How to take the tablets
Swallow each tablet whole with a glass of water.
COLCARDIOL should be taken once daily and can be taken at any time of day, with or without food.
Try to take the tablets at approximately the same time each day; this may help you remember to take them.

Periodic cholesterol checks
It is important to return to your doctor for regular cholesterol level checks to ensure that your cholesterol has reached and maintains the correct levels. Your doctor may decide to increase your dose until the most appropriate amount of COLCARDIOL for you is reached.

If you take more COLCARDIOL than you should
Contact your doctor or the nearest hospital for advice.
If you go to hospital or receive treatment for another condition, inform the hospital doctor that you are taking COLCARDIOL.

If you forget to take COLCARDIOL
Do not panic; take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking COLCARDIOL
Inform your doctor if you intend to stop taking COLCARDIOL. If you stop taking COLCARDIOL, your cholesterol levels may rise again.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
It is important to be aware of which of these side effects may occur.
They are usually mild to moderate and short-lived.
Stop taking COLCARDIOL and seek immediate medical help if you experience any of the following allergic reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue and/or throat;
• swelling of the face, lips, tongue and/or throat which may cause difficulty swallowing;
• severe itching of the skin (with raised hives);
• red, non-raised spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking COLCARDIOL and contact your doctor immediately if you have:

• Unusual muscle pains or aches lasting longer than expected. Muscle-related symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially life-threatening, known as rhabdomyolysis.
• If you experience muscle tearing.
• If you develop lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).

Possible side effects
Common (may occur in 1 to 10 and 1 to 100 patients)

• headache;
• stomach pain;
• constipation;
• feeling unwell;
• muscle pain;
• feeling weak;
• dizziness;
• increased levels of protein in the urine – values usually return to normal on their own without needing to stop COLCARDIOL (only for COLCARDIOL 40 mg);
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon (may occur in 1 to 100 and 1 to 1000 patients)

• rash; itching and other skin reactions;
• increased levels of protein in the urine – these usually return to normal on their own without needing to stop treatment with COLCARDIOL (only for COLCARDIOL 5 mg, 10 mg and 20 mg).

Rare (may occur in 1 to 1000 and 1 to 10,000 patients)

• severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised hives); if you suspect an allergic reaction, stop taking COLCARDIOL and seek immediate medical help;
• muscle damage in adults – as a precaution, stop taking COLCARDIOL and contact your doctor immediately if you have unusual muscle pains or aches that last longer than expected;
• severe stomach pain (inflamed pancreas);
• increased liver enzymes in the blood;
• bleeding or bruising more easily than normal due to low platelet count in the blood;
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
• muscle tearing.

Very rare (may occur in fewer than 1 in 10,000 patients)

• jaundice (yellowing of the skin and eyes);
• hepatitis (inflammation of the liver);
• traces of blood in the urine;
• nerve damage in arms and legs (numbness);
• joint pain;
• memory loss;
• breast enlargement in men (gynaecomastia).

Not known (cannot be estimated from available data):

• diarrhoea (passing loose stools);

• cough;

• shortness of breath;

• oedema (swelling);

• sleep disorders, including insomnia and nightmares;

• sexual problems;

• depression;

• breathing problems, including persistent cough and/or shortness of breath or fever;

• tendon injury;

• constant muscle weakness.

• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).

• Ocular myasthenia (a disease causing weakness of the eye muscles). Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or breathlessness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store COLCARDIOL

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What COLCARDIOL Contains
The active substance is rosuvastatin. COLCARDIOL film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
The other components are:
Film-coated tablets 5 mg
Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, quinoline yellow (E104).
Film-coated tablets 10 mg
Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, Allura red (E129).
Film-coated tablets 20 mg
Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, carmine (E120).
Film-coated tablets 40 mg
Core: microcrystalline cellulose, monohydrate lactose, crospovidone, magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, sunset yellow (E110), cochineal red (E124).

Description of the Appearance of COLCARDIOL and Pack Contents
COLCARDIOL 5 mg tablets are yellowish, film-coated, round-shaped, with " 5 " engraved on one side.
COLCARDIOL 10 mg tablets are light pink, film-coated, round-shaped, with " 10 " engraved on one side.
COLCARDIOL 20 mg tablets are dark pink, film-coated, round-shaped, with " 20 " engraved on one side.
COLCARDIOL 40 mg tablets are red, film-coated, round-shaped, with " 40 " engraved on one side.
The tablets are available in PA/Aluminum/PVC-ALU blisters, pack size: 28 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Euro-Pharma S.r.l.
Via Garzigliana n. 8
10127 Torino, Italy

Manufacturer Responsible for Batch Release
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland